Australia ideal for early-stage drug development

Australia does not represent a large end-user drug market, and is not a low-cost producer, but increasingly is positioning itself as a niche global provider of an integrated set of world-class capabilities in these translational areas. The pressure on time-to-market for pharma developers is intense. This pressure is made worse in the case of biologics, since they are typically more complex materials than traditional small molecule drugs. This complexity often adds to the time needed to characterize and validate the efficacy of the product, and to develop production processes that consistently and economically manufacture the active drug. This extended development time eats into the patent life available to exploit the new drug and recover the development costs. These pressures favour use of quality providers with a strong, demonstrable track record of doing projects right the first time. It is into this niche that Australia logically positions itself.

The Australian commercial environment offers good IP protection, with advanced legal and financial systems, and a stable government, all of which provide a familiar and welcoming backdrop for the biopharma developer scouring the globe for the best outsourcing solution. In this context, 'best' means the lowest-risk opportunity for on-time, on-budget outcomes of clinical development projects.

Australia's regulatory processes are harmonized with the advanced Western jurisdictions, and with world-class services available across the entire translational spectrum, the client need not go any further to access an entire suite of outsourcing requirements. The future clients of the DSMB Brisbane facility may also locally access pre-clinical services at Tetra Q, set up their clinical trials using CNS, obtain regulatory advice from Ground Zero or ERA Consulting, and perform their phase I trials with Q Pharm.

Technology transfer is an expensive undertaking, and the management of such transfer is made more difficult by time zone disparity. As a quality supplier, and in the same time zone, Australia is ideally situated to service the future needs of the Asian region. In countries such as Singapore, Taiwan and China, there has been heavy investment in recent years in biomedical research infrastructure. As these institutions begin to mature and generate commercial drug candidates, Australia's capabilities should become increasingly attractive, and provide the opportunity for leveraging its strengths to become a regional hub for clinical development of biologics.